Kornimate/medical-research-clean huggingface dataset:
heartland osteoporosis prevention study

Conditions: Osteopenia

Summary: the purpose of this study is to identify the best way to prevent bone loss in the first years after menopause. the hops study will compare bone loss at 12 months in women: 1) who take calcium and vitamin d only; 2) who take calcium and vitamin d plus the medication "risedronate"; or 3) who take calcium and vitamin d plus participate in bone-loading exercises. our central hypothesis is that improvements in bone health will be greater in women randomized to bone-loading exercises with calcium and vitamin d compared to women who take calcium and vitamin d only or women who take calcium and vitamin d plus risedronate.

this randomized controlled trial (rct) will compare changes after 12 months in bone structure, bone mineral density (bmd), and bone turnover in women with low bone mass who are within 5 years of menopause. women will be randomized to one control and 2 treatment groups (n =103 per group): 1) calcium + vitamin d (cad) alone (control); 2) bisphosphonate (bp) plus optimal cad (risedronate); and 3) a bone loading exercise program plus optimal cad (exercise). our central hypothesis is that improvements in bone health will be greater in subjects randomized to the exercise group compared to subjects in either the control or risedronate groups. specific aims: aims 1, 2, and 3 are to compare control, risedronate, and exercise group subjects on changes in bone structure at the tibia and hip (measured by pqct and hip structural analysis) (aim 1) ; on changes in bmd at the total hip, femoral neck, and spine (aim 2); and on changes in serum markers of bone formation and resorption (aim 3). in addition, aim 4 will explore relationships between adherence to exercise (% sessions attended) or adherence to risedronate (% pills taken) and changes in bone structure.

Eligibility criteria:
inclusion criteria: * women who are in their first 5 years of menopause * have a t score between -1 and -2.49 at the femoral neck, total hip, or l1-l4 spine * be 19 years of age or older * have their health care provider's permission to enroll in the study. exclusion criteria: * have osteoporosis * have a 10 yr probability of hip fracture \>3% or major fracture \>20% based on results of the fracture risk assessment (frax) tool * currently take bisphosphonates, estrogen replacement therapy, glucocorticosteroids, or other drugs affecting bone * currently participate in a resistance training or high impact weight bearing exercise program three or more times weekly * weigh \>300 lbs * have abnormal results for the following laboratory tests: serum 25(oh)d; serum creatinine; serum calcium; parathyroid hormone (pth); thyroid stimulating hormone (tsh). * have paget's disease, heart disease, uncontrolled hypertension, renal disease, or other concomitant conditions that prohibit participation in exercises, risedronate therapy, or use of cad supplements.

Keywords: low bone mass post-menopausal women bone mineral density bone structure bone turnover bone-loading exercises calcium and vitamin d risedronate
a virtual support intervention for postnatal well-being

Conditions: Postnatal Depression; Mother-Infant Interaction

Summary: postnatal depression (pnd) and anxiety are significant public health concerns affecting a substantial proportion of new mothers worldwide. these conditions can have profound consequences for both maternal and infant well-being, including increased risk of 1. maternal morbidity 2. impaired parent-infant bonding 3. long-term developmental challenges for the child.

despite the prevalence and impact of pnd and anxiety, access to timely and effective mental health care for postpartum women remains limited, particularly in resource-constrained settings. limited research: there has been a historical underinvestment in mental health research in pakistan, especially in maternal mental health. cultural stigma: mental health issues, particularly postpartum depression, are often stigmatized, leading to underreporting. data infrastructure: robust data collection and analysis systems for mental health are still developing in pakistan the rationale for this study is grounded in the significant public health burden imposed by postnatal depression (pnd) and anxiety, coupled with the limitations of traditional care models. despite advancements in maternal and child health, postpartum mental health remains a neglected area in many countries, including pakistan.

Eligibility criteria:
inclusion criteria: * pakistani female aged 18-45 years * recent childbirth (within 0-6 weeks) * access to a smartphone or computer with internet connectivity * able to understand and communicate in urdu or english * willing to provide informed consent exclusion criteria: * pre-existing severe mental illness (e.g., schizophrenia, bipolar disorder) * current substance abuse or dependence * limited or no access to the internet or smartphone * inability to understand or communicate in urdu or english * pregnancy complications requiring intensive care * infants with severe medical conditions requiring hospitalization
strength training and different subtypes of parkinson´s disease

Conditions: Parkinson Disease

Summary: the aim of this randomized controlled trial was to assess the impact of progressive resistance exercise (pre) in pd patients with akinesia and rigidity (ar-subtype). the investigators hypothesized the intervention would have a beneficial effect on the study outcomes.

twenty-eight patients with pd ar-type of both sexes, were recruited for this trial. each participant were assigned randomly to either intervention (n=13) or control (n=15) group. the intervention group participated in sixteen pre training sessions for eight weeks: two sessions per week on non-consecutive days, sixty-seventy min each one. the control group followed their usual weekly physical activity routine. all patients underwent antrophometrical and neuromuscular function assessment (cop measurements -primary outcomes- and the ten-meters walk test -tmwt- -secondary outcomes-). in addition, they were asked to provide ratings for the spanish validated versions of the the freezing of gait questionnaire (fog-q, 6-item version) -secondary outcomes-, the 39-item parkinson ́s disease questionnaire (pdq39) -secondary outcomes- and the mds-updrs -secondary outcomes-. additionally, ratings of perceived exertion (rpe) (borg \>6-20 scale) - secondary outcomes-, were recorded at the end of each pre training session. tests were carried out at three times: pre-test (before the training program), post-test (eight weeks after pre-tests, at the end of the training period), and four weeks after the post-test (re-test).

Eligibility criteria:
inclusion criteria: * diagnosed with pd ar-type and hoehn and yahr scale 1-2, (h\&y) * do not express any type of dementia * able to stand for two min without assistance; * able to walk ten metres without assistance. exclusion criteria: * to suffer a neurological disease other than pd. * do not meet some of the inclusion criteria.
care-hf cardiac resynchronization in heart failure

Conditions: Heart Failure

Summary: the care-hf trial evaluates the effects of cardiac resynchronization (cr) therapy on the mortality and morbidity of patients with heart failure due to left ventricular systolic dysfunction already receiving diuretics and optimal medical therapy.

813 patients enrolled 82 centers in 12 countries (austria, belgium, denmark, finland, france, germany, italy, netherlands, spain, sweden, switzerland, and uk)

Eligibility criteria:
inclusion criteria: * heart failure for at least 6 weeks requiring loop diuretics * currently in nyha class iii/iv * a high standard of pharmacological therapy * lv systolic dysfunction and dilation (ef \ 30mm/height in metres) * qrs \>=120 ms dyssynchrony confirmed by echo if qrs 120-149 ms (aortic pre-ejection delay \>140ms, interventricular mechanical delay \>40 ms, delayed activation of postero-lateral lv wall) exclusion criteria: * age \< 18 years old or age \< legal age defined in the country in case different * chronic atrial fibrillation within 6 weeks prior to randomization; * impairment of left ventricular function not related to left ventricular systolic function * potentially reversible forms of cardiomyopathy: * cardiac surgery, percutaneous coronary intervention, cardiomyoplasty, myocardial infarction,unstable severe angina or stroke within 6 weeks before randomization * a conventional indication for bradyarrhythmia pacing exists; * a conventional indication for an icd exists * a pacemaker or icd has already been implanted; * in-patients requiring continuous intravenous therapy for heart failure; * life expectancy \< 1 year for disease unrelated to heart failure; * pregnancy or childbearing potential and not on reliable contraceptive; * mechanical tricuspid valve; * anticipated compliance problem or participation in another trial;

Keywords: cardiac resynchronisation therapy (crt therapy), all-cause mortality, quality of life assesment, echocardiographic left ventricular function, crt and neurohormonal activation, crt and health economics
diet-induced variability in appetite (diva)

Conditions: Overweight and Obesity

Summary: the aim of this study is to test the hypothesis that dietary weight loss (wl) through alternate day fasting (adf) will enhance appetite control, health markers and wellbeing following wl compared to standard daily calorie restriction (cr).

this is a proof of concept randomized controlled trial in which overweight/obese females will be randomised to a dietary weight loss intervention (adf or cr) to achieve ≥5% wl. behavioural measures of appetite control including ad libitum intake after a fixed meal, body composition, resting metabolic rate, measured physical activity and daily energy expenditure, sleep quality, hedonic food reward and eating behaviour traits will be assessed before, during and after the wl intervention in those who reach the target weight loss within 12 weeks. after weight loss phase, participants will be given standard healthy eating and physical activity advice for weight maintenance and body weight will be followed up after weight loss at 12 months.

Eligibility criteria:
inclusion criteria: * female participants aged between 18 and 55 years at the time of signing informed consent * bmi of 25.0 - 34.9 kg/m2 exclusion criteria: * significant health problems which in the opinion of the investigator, might jeopardise participant's safety or compliance with the protocol * currently enrolled in a weight loss programme or following a specific diet plan. * history of eating disorders including binge eating. * taking any medication or supplements known to affect appetite or weight within the past month and/or during the study * pregnant, planning to become pregnant or breastfeeding * history of anaphylaxis to food * known food allergies or food intolerance * smokers and those who have recently ceased smoking (\< 6 months) * bmi \ 35 kg/m2 * volunteers having lost significant amount of weight in the previous 6 months (± 4kg) * volunteers who exercise \> 3 days per week or have significantly changed their physical activity patterns in the past 6 months or who intend to change them during the study * participants receiving systemic or local treatment likely to interfere with evaluation of the study parameters * participants who work in appetite or feeding related areas. * participants who do shift work
optivate in people with von willebrand disease undergoing surgery

Conditions: Von Willebrand Disease

Summary: an open, multi-centre study in patients with von willebrand disease (vwd) undergoing surgery.


Eligibility criteria:
inclusion criteria: 1. have given written informed consent. 2. be aged 12 years or older. 3. have vwd of known type. 4. be due to undergo surgery, in which the investigator believes a vwf concentrate will be required. 5. have a known lack of, poor response to, or contraindication to, ddavp, or require a type of surgery in which a plasma-derived product is appropriate. 6. have a prothrombin time (pt) of not more than 3 seconds above the upper limit of the reference range. 7. female patients of child-bearing potential, with the exception of pregnant patients undergoing caesarean surgery or other modes of delivery, including normal vaginal delivery, must have a negative result on a human chorionic gonadotropin-based pregnancy test. if a female patient is or becomes sexually active, she must practice contraception by using a method of proven reliability for the duration of the study. exclusion criteria: 1. have a history of inhibitor development to vwf or fviii or a positive result at screening (positive screen for vwf inhibitor; positive screen and a result of \>0.5 bu for fviii inhibitor). a result at screening is not mandatory if the patient is to undergo emergency surgery and the local laboratory is unable to perform the analyses. 2. patients with thrombocytopenia (platelets \<50 x 109/l). 3. patients who have clinically significant renal disease (creatinine \>200 µmol/l). 4. patients who have clinically significant liver disease (alt levels greater than three times the upper limit of the reference range). 5. presence of any other major systemic illnesses which would compromise the outcome of the study in the opinion of the investigator. 6. known or suspected hypersensitivity to investigational medicinal product (imp) or its excipients. 7. have a recent history of alcohol or drug abuse. 8. administration of a new chemical entity within the 4 months preceding enrolment. 9. participation in any other clinical study in which investigational or marketed drugs were employed in the 30 days preceding enrolment (screening visit) into this study, with the exception of the bpl clinical study protocol 8vwf01. 10. female patients who are lactating. 11. in the opinion of the investigator, the patient is unlikely to comply with the study protocol.
olopatadine 0.2% for the treatment of allergic conjunctivitis

Conditions: Allergic Conjunctivitis

Summary: the purpose of this study is to demonstrate that olopatadine 0.2% is superior to vehicle in the treatment of the signs and symptoms associated with allergic conjunctivitis or rhinoconjunctivitis.


Eligibility criteria:
inclusion criteria: * history of seasonal allergic conjunctivitis or rhinoconjunctivitis, a positive grass antigen challenge reaction (skin test), and a positive response to grass in the conjunctival allergen challenge (cac) model exclusion criteria: * under 10 years of age
understanding and treating traumatic brain injury (tbi) associated photophobia with botulinum toxin type a (bont-a)

Conditions: Traumatic Brain Injury

Summary: the purpose of this research is to understand and treat traumatic brain injury (tbi) associated photophobia (light sensitivity) and its impact on visual function.


Eligibility criteria:
inclusion criteria: * recruit and enroll male and female subjects, civilians and veterans (1:1 mix anticipated, i.e., n = 25 from each group) of all races and ethnicities. * ≥18 years of age who are able to consent. * report chronic photophobia (numerical rating scale ≥4 on a 0-10 scale, photophobia present ≥6 months) with a remote history of tbi (\>1 year). * inclusion into the study with regard to tbi status will be based on the department of defense standard surveillance case definition for tbi adapted for armed forces health surveillance division (afhsb) use. this can include one hospitalization or outpatient medical encounter with documented international classification of diseases (icd9/icd10) codes as identified within the surveillance case definition. * subjects must also have been on a stable medication regimen for the past 3 months and must be naïve to bont-a treatment for orofacial conditions. * english as primary language (by self-report). exclusion criteria: * individuals with ocular diseases that may confound photophobia, such as glaucoma, corneal and conjunctival scarring, corneal edema, uveitis, iris transillumination defects, retinal degeneration, etc. * patients who are participating in another study with an investigational drug within one month prior to screening. * pregnant individuals. pregnant subjects will not be scanned in the functional magnetic resonance imaging (fmri). although there are no known risks associated with mri during pregnancy, according to facility policy, university of miami will not scan someone that is pregnant. therefore, all women of childbearing potential (menstruating or \>12 years old) must complete a for stating that are not pregnant within 24 hours of each mri scan. * individuals with contraindications to fmri scanning (e.g. metal implants, pacemaker) will not be offered inclusion.
journaling intervention for temporomandibular disorder (tmd) and chronic overlapping pain

Conditions: Temporomandibular Disorders (TMD)

Summary: the goal of this clinical trial is to learn whether a 2-week gratitude journaling activity is feasible and acceptable for individuals with temporomandibular disorder (tmd) and chronic overlapping pain. the study will also look at whether this activity is helpful in reducing pain and how much it interferes with daily life. the primary aims of this study are to: * assess whether individuals with tmd and chronic overlapping pain are able to complete the 2-week gratitude journaling activity as planned (feasibility). * evaluate how acceptable participants find the gratitude journaling activity (acceptability). the secondary aim of this study is to: • explore whether the gratitude journaling activity reduces pain and its impact on daily life, compared to a general wellness journaling activity. participants will: * attend two in-person visits to complete questionnaires and take part in tests that measure how sensitive they are to pressure and heat. * complete a 2-week journaling activity at home, writing in their journal on three days of their choice per week.


Eligibility criteria:
inclusion criteria: * participants between the ages of 18 and 80 * pain in the temporomandibular (tmd) region (jaw and/or temple area) * duration of pain is at least 3 months * average pain score ≥4 on a 0-10 numerical rating scale over the past week * have at least one additional chronic overlapping pain condition (copc) including fibromyalgia, irritable bowel syndrome, migraine-type headache, tension-type headache, low back pain, interstitial cystitis/painful bladder syndrome or chronic prostatitis, myalgic encephalomyelitis/chronic fatigue syndrome, vulvodynia, and painful endometriosis. * able to read, understand, and write in english. exclusion criteria: * history of tmd surgery * neoplasm or injury/trauma to the tmd area * cancer-related pain * scheduled for any surgeries during the study time-frame * current participation in another clinical trial or psychological treatment for any pain-related condition that would interfere with study outcomes * pregnant or lactating * severe motor impairments (e.g., muscular dystrophy) * severe psychiatric conditions (e.g., uncontrolled mood disorders) * severe neurological or cognitive impairments (e.g., uncontrolled parkinson's disease) * any other conditions that in the opinion of study investigators could make participation in the study unsafe * use of opioids within 48 hours prior to laboratory visit

Keywords: temporomandibular disorder gratitude journaling resilience pain intensity pain interference chronic pain
feasibility study of a chronic retinal stimulator in retinitis pigmentosa

Conditions: Retinitis Pigmentosa

Summary: the objective of this study is to evaluate the safety and efficacy of the retinal stimulation system by evaluating the data after chronic implantation.

the chronic retinal stimulation system is an implantable electronic device designed to provide electrical stimulation of the retina in order to elicit visual percepts in blind subjects. this chronic feasibility study will evaluate the ability of subjects to resolve multiple percepts and patterns under various stimulus conditions and optimize the effectiveness of electrical stimulus parameters with an initial chronic design.

Eligibility criteria:
inclusion criteria: * confirmed history of retinal degenerative disease in the worse seeing eye with remaining vision no better than light perception. the fellow eye can have any visual acuity but must have better vision than the eye that will have the surgery. * history of former useful form vision in worse-seeing eye * acceptable ability to describe visual percepts * age eighteen (18) or older exclusion criteria: * history of glaucoma * optic neuropathy or other confirmed damage to optic nerve or visual cortical damage * presence of communicable disease/infection * pregnancy * history of claustrophobia * inconsistent flash detection thresholds * any other diseases that can effect the function of the retina * subjects with a beck depression inventory interpretation score of \>30 and subsequent diagnosis of depression by a psychiatrist. * corneal degeneration
transdermal methylphenidate for cancer-related fatigue

Conditions: Head and Neck Cancer

Summary: the purpose of this study is to compare the effects, good and/or bad, of the methylphenidate patch and a placebo patch (a patch that contains no medicine) on patients and their fatigue caused by cancer or by cancer treatment. the methylphenidate patch contains a medication that is known to increase alertness and wakefulness. oral methylphenidate has been used in the past to treat cancer related fatigue and is often used to treat unusual sleepiness. but this is the first time that the patch form is offered to try treating cancer fatigue in patients who cannot always swallow tablets.


Eligibility criteria:
inclusion criteria: * diagnosis of head and neck cancer who underwent combined modality treatment with curative intent * has not undergone cancer treatment in the last 4 weeks * is 21 years of age or older * fatigue scale score of 4 or higher * is able to understand english, through written and verbal communication * in the judgment of the consenting professional, is able to provide informed consent * physically able to present for follow-up appointments at outpatient radiation oncology or pain \& palliative care clinics * probable life expectancy of more than 6 months exclusion criteria: * pulmonary or cardiovascular failure, seizure disorder, sleep disorder, mental impairment, psychiatric disorder, or pregnancy * has known sensitivity or allergies to methylphenidate * receiving concurrent treatment with a psychostimulant * hospitalized patients * evidence of impaired hepatic or renal function (hyperbilirubinemia, greater than two fold elevation of transaminases; \>40mg/dl bun or \>1.5mg/dl cr ) * anemia ( hemoglobin \<10mg/dl)

Keywords: methylphenidate transdermal patch placebo fatigue 10-020